Ischaemic heart disease MedDRA version: 20.0 Level: LLT Classification code 10023024 Term: Ischaemic heart disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10008937 Term: Chronic ischemic heart disease, unspecified System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT C
Conditions
Sponsors
Rigshospitalet, Department of Physiology, Nuclear Medicine and PET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are patients diagnosed with chronic occlusion of the coronary being treated with Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft(CABG) operation. The patients must be above the age of 18 years, and must be capable of understanding and giving full informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: The principal exclusion criteria are: 1. Patient who prior underwent cardiac surgery 2. Patient recieving anti-angiogenetick treatment 3. Patient with known allergi towards interveneous contrast 4. Patient with pacemaker, cochlear implant or insulinpump 5. Pregnancy 6. Lactation 7. Obesity (weight above 140 kg) 8. Claustrophobia 9. Re-operation after intervention 10. Conversion to open surgery during intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to test a new radio tracer called 68Ga-NODAGA-E-[RGDyK]2 for PET imaging of angiogenesis. The tracer has the potential of identifying heart tissue with a high level of angiogenesis. Angiogenesis is a very important factor in reparing heart tissue. Therefor, the tracer can potentially be used to asses how the tissue respons to the chosen therapy. ;Secondary Objective: non applicable;Primary end point(s): To evaluate myocardial angiogenesis using 68Ga-NODAGA-E-[RGDyK]2 after intervention;Timepoint(s) of evaluation of this end point: The patient will be PET scanned after injection af the radio tracer 68Ga-NODAGA-E-[RGDyK]2. The patient will be scanned on two different days: 1. Scan: 14-21 days prior intervention 2. Scan: 30-35 days after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and change in myocardial perfusion after intervention - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and functional recovery 30 days after intervention - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and viability before and after intervention;Timepoint(s) of evaluation of this end point: Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 in the Heart will be assessed by PET scans after injection. | — |
Countries
Denmark
Contacts
Public ContactJohanne Madsen
Rigshospitalet, Department og Clinical Physiology, Nuclear Medicine and PET
Outcome results
None listed